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CBD sales hit an all-time high in 2019 and surpassed the billion-dollar mark. It seems like people can’t get enough of the tinctures, roll-ons, topicals, and edibles that anecdotally give relief from many ailments. And while hemp-derived CBD is no longer a controlled substance under federal drug laws, it is still in legal limbo in terms of how companies can market it and how people can use it. That’s because the Food and Drug Administration (commonly known as the FDA), which is the federal government agency charged with making sure foods, beverages, drugs, and supplements are safe for human consumption, isn’t convinced CBD is safe yet.
In November, the FDA issued warning letters to 15 companies that sell CBD in food products, stating that marketing CBD in food products or as a supplement is against the law.
The FDA stated in a recent bulletin that it cannot yet designate CBD as “GRAS,” or Generally Regarded as Safe, because there isn’t enough long-term research to show what CBD does and does not do. Since hemp and marijuana are in the same plant family and were legally banned as controlled substances for many years, scientists and medical researchers couldn’t fully study their potential benefits. The studies that do exist show many positive affects in people from the use of CBD, but there have also been some concerns raised.
The biggest concern is that CBD use may affect the liver. In some studies, subjects who took CBD showed elevated liver enzyme levels with repeated use. Because CBD and medications are both metabolized by the liver, taking CBD while on prescriptions could change the way medicines are released in the body. This is similar to the way grapefruit can have an impact on prescription drug use. The FDA bulletin also states that the reproductive capability of male test animals was negatively impacted when they were dosed with CBD. The bulletin further pointed out that CBD may cause side effects such as drowsiness or insomnia, irritability, and diarrhea or stomach upset in some people.
“There are many important aspects about CBD that we just don’t know,” the FDA update says. “Such as:
Proponents of CBD believe the FDA is being overly cautious about approving a natural substance that has never caused a single death or overdose – ever. The Expert Committee on Drug Dependence for the World Health Organization (WHO) completed its review of CBD in 2018 and concluded the following:
Advocates for CBD point out that there are many FDA-regulated and approved medications that have caused deaths, addictions, and far more serious side effects than CBD has shown so far. However, the FDA is not yet convinced. Bottom line: the FDA wants to see more studies that prove CBD is beneficial, not harmful, before it gives CBD the full thumbs-up.
The FDA enforces the federal Food, Drug & Cosmetic Act by making sure products that go into or on human or pet bodies are safe, that the labels on them aren’t making false claims, and that the marketing isn’t misleading people. The FDA also regulates products by setting up guidelines and standards for how foods, drugs, supplements, and cosmetics are made, labeled, and advertised to the American public.
CBD products with less than 0.3% THC can be manufactured legally in many states and legally sold interstate. Consumers can buy and use CBD products. But companies aren’t supposed to make claims that CBD will do anything to improve health or treat any physical conditions. The FDA admits CBD products are readily and widely available, but warns that people will be safer if they wait until regulations and standards have been developed, approved, and applied before they buy and try CBD.
The only FDA-approved medication containing pure CBD is Epidiolex, which got the FDA stamp of approval in July 2018. Epidiolex is used to treat two severe forms of epilepsy, as it has been shown to greatly reduce seizures, especially in children. CBD has not been approved for the treatment of any other physical, mental, or emotional conditions to date.
In the FDA’s recent warning letters, the administration noted that CBD is an active ingredient in an approved drug and that “allowing drug ingredients in foods can undermine the drug approval process and diminish commercial incentives for further clinical study of the relevant drug substance.”
In plain English that means pharmaceutical companies may not be interested in investing big bucks to study CBD if the public can already get their hands on it easily.
One thing CBD companies and the FDA agree on is that standards need to be developed quickly so consumers can be assured they are buying and using only high-quality products. Recently, the FDA tested wide samplings of readily available CBD products and found that the ingredients were all over the place. Some contained no CBD at all. Some had more THC than is legally permitted. Some had toxins. Without standards in place, the CBD market has been compared to the “Wild West,” where hucksters sold “snake oil” to gullible folks.
Hemp is a bioaccumulator, which means it is a plant that pulls in everything from the soil in which it is grown. Hemp plants grown in contaminated soil will produce CBD that has contaminants – from pesticides to heavy metals. Plus, with standards and regulations, companies can currently package or bottle just about anything and say it has CBD in it without any way of proving it to the buyer.
“In addition to safety risks and unproven claims, the quality of many CBD products may also be in question,” the FDA says. “The FDA is also concerned that a lack of appropriate processing controls and practices can put consumers at additional risks. For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed.”
While CBD companies and consumer watch and wait for the FDA to develop the regulations needed, it is important to use caution when buying and taking products with CBD. When making any changes to your health routine, consult with your medical professionals so they can closely monitor dosages and effects. Make sure you choose a CBD product that has been tested by an outside, independent laboratory and that the manufacturer is open about letting buyers see those test reports. You want to receive the full benefits of CBD without any other harmful ingredients.
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